Tag: approval

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Glaxo’s Injectable Asthma Treatment ‘Nucala’ Gets Approval From FDA – International Business Times


International Business Times

Glaxo's Injectable Asthma Treatment 'Nucala' Gets Approval From FDA
International Business Times
The U.S. Food and Drug Administration (FDA) has given a go ahead to GlaxoSmithKline Plc's drug Nucala for treatment of severe asthma. The regulato6ry body said that the drug can be used in combination with other therapies and medications for asthma …
FDA Approves New Asthma MedicationSMN Weekly (blog)
Mepolizumab gets green signal from FDA to be used for maintenance treatment of …NYC Today
GlaxoSmithKline plc (ADR): Why Nucala's FDA Approval Is SignificantBidness ETC

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EU regulator backs approval for GSK injectable asthma drug – Yahoo News


Yahoo News

EU regulator backs approval for GSK injectable asthma drug
Yahoo News
The treatment could help boost GSK's respiratory drugs business as demand weakens for its asthma drug, Advair. A significant minority of asthma patients do not respond to regular inhalers such as Advair, Dulera and Flovent, creating what analysts …
Glaxo asthma drug clears key hurdle in EuropeMarketWatch
CHMP Backs Mepolizumab for Severe Eosinophilic AsthmaMedscape
GlaxoSmithKline's asthma injection heads for EU approvalFierceBiotech
Bidness ETC
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EU regulator backs approval for GSK injectable asthma drug – Reuters


Reuters

EU regulator backs approval for GSK injectable asthma drug
Reuters
GlaxoSmithKline Plc said the European health regulator had recommended an approval for its injectable drug to treat asthma patients who don't respond well to traditional inhalers. The European Commission is expected to decide on a final approval for …
Glaxo asthma drug clears key hurdle in EuropeMarketWatch
GlaxoSmithKline's asthma injection heads for EU approvalFierceBiotech
Europe's CHMP give thumbs up to Glaxo's Nucala for severe asthmaSeeking Alpha

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GSK Gets Canadian Approval For BREO ELLIPTA For Treatment Of Asthma In Adults – Nasdaq

GSK Gets Canadian Approval For BREO ELLIPTA For Treatment Of Asthma In Adults
Nasdaq
BREO® ELLIPTA is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. Two strengths, 100/25 mcg and 200/25 mcg, have been approved in Canada for use in asthma. BREO is administered …
GSK-Theravance's Breo Ellipta gets Canadian approval to treat asthma in adultsPharmaceutical Business Review
GSK Receives Approval for BREO(R) ELLIPTA(R) for the Treatment of Adults With …MarketWatch

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GSK Gets Canadian Approval for BREO ELLIPTA for Treatment of Asthma in Adults – RTT News

GSK Gets Canadian Approval for BREO ELLIPTA for Treatment of Asthma in Adults
RTT News
GlaxoSmithKline plc (GSK) and Theravance, Inc. (THRX) on Thursday announced the approval in Canada of BREO ELLIPTA for the once-daily maintenance treatment of asthma in patients aged 18 years and older with reversible obstructive airways disease.
GSK Receives Approval for BREO(R) ELLIPTA(R) for the Treatment of Adults With …MarketWatch

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FDA Committee Recommends Approval Of Nucala For Adult Asthma Patients – Lung Disease News


Lung Disease News

FDA Committee Recommends Approval Of Nucala For Adult Asthma Patients
Lung Disease News
An FDA advisory committee recently voted unanimously to approve Nucala for the treatment of severe asthma with eosinophilic inflammation in patients 18 and older. The committee, however, decided against the use of the therapy in adolescents aged …
GSK's new asthma biologic gains FDA panel backingPMLiVE

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UPDATE 1-FDA panel backs approval of GSK asthma drug in adults – Reuters


MedPage Today

UPDATE 1-FDA panel backs approval of GSK asthma drug in adults
Reuters
If approved, the drug would be marketed under the trade name Nucala and be the first new biologic treatment for severe asthma in more than a decade. Asthma affects more than 22 million people in the United States. Severe asthma accounts for 5 to 10 …
UPDATE: Glaxo's (GSK) Severe Asthma Drug Mepolizumab Found Effective in …StreetInsider.com
Asthma Drug Targeting IL-5 Wins Partial Backing From FDA AdvisersMedPage Today
FDA committee recommends approval of Nucala for adults with severe asthmaHealio
Reuters India
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FDA panel backs approval of GSK asthma drug in adults – Reuters


Reuters

FDA panel backs approval of GSK asthma drug in adults
Reuters
An advisory committee to the U.S. Food and Drug Administration recommended approval on Thursday of GlaxoSmithKline Plc's drug mepolizumab for severe asthma in patients aged 18 and older. The panel voted 10 to 4 against approving it in children aged …
UPDATE: Glaxo's (GSK) Severe Asthma Drug Mepolizumab Found Effective in …StreetInsider.com
FDA committee recommends approval of Nucala for adults with severe asthmaHealio

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